Trial Outcomes & Findings for Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap (NCT NCT01575756)
NCT ID: NCT01575756
Last Updated: 2018-03-09
Results Overview
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The mean ratio of normalized area under the curve was calculated as Octafibrin/FIBRYGA® over Haemocomplettan® P/RiaSTAP(TM)
COMPLETED
PHASE2
22 participants
Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment
2018-03-09
Participant Flow
Participant milestones
| Measure |
Octafibrin/FIBRYGA® Followed by Haemocomplettan® P/RiaSTAP(TM)
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once followed by Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once 45 days later.
|
Haemocomplettan® P/RiaSTAP(TM) Followed by Octafibrin/FIBRYGA®
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once followed by Octafibrin/FIBRYGA® 70 mg/kg BW intravenously once 45 days later.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
11
|
11
|
|
Treatment Period 1
COMPLETED
|
11
|
11
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
11
|
11
|
|
Treatment Period 2
COMPLETED
|
11
|
11
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
Baseline characteristics by cohort
| Measure |
Full Analysis Set
n=22 Participants
All randomised participants who received at least 1 infusion of study medication (Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)) and for whom any post-treatment data were available.
|
|---|---|
|
Age, Continuous
|
26.0 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The mean ratio of normalized area under the curve was calculated as Octafibrin/FIBRYGA® over Haemocomplettan® P/RiaSTAP(TM)
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized
|
1.196 ratio
Interval 1.117 to 1.281
|
—
|
PRIMARY outcome
Timeframe: 1 hour post-treatmentPopulation: Full analysis set: All randomised participants who received at least 1 infusion of study medication (Octafibrin/FIBRYGA®) and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)) and for whom any post-treatment data were available.
Thromboelastometry (ROTEM®) was used to measure maximum clot firmness. Thromboelastometry is a method for the continuous measurement of clot formation. Maximum clot firmness is a functional parameter that depends on the activation of coagulation, the platelet and fibrinogen content of the blood sample, and the polymerisation and cross-linking of the fibrin network. In order to obtain comparable results from all study centres, maximum clot firmness data were assessed from frozen citrated plasma samples in a central laboratory. As these samples did not contain platelets that would be found in the whole blood assay, the fibrinogen content primarily defined the maximum clot firmness.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=22 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=22 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion
|
9.68 mm
Interval 8.37 to 10.99
|
10.00 mm
Interval 8.07 to 11.93
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Fibrinogen Activity Normalized Area Under the Curve Unstandardized
|
1.62 h•kg•g/L/mg
Standard Deviation 0.45
|
1.38 h•kg•g/L/mg
Standard Deviation 0.47
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The normalized area under the curve was standardized to a dose of 70 mg/kg.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Fibrinogen Activity Normalized Area Under the Curve Standardized
|
113.70 g•h/L
Standard Deviation 31.54
|
96.39 g•h/L
Standard Deviation 32.89
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Maximum Plasma Concentration Normalized (Cmaxnorm)
|
0.018 kg•g/L/mg
Standard Deviation 0.005
|
0.018 kg•g/L/mg
Standard Deviation 0.005
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) Unstandardized
|
1.390 g/L
Standard Deviation 0.369
|
1.265 g/L
Standard Deviation 0.309
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses; had any post-T data; did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The maximum plasma concentration was standardized to a dose of 70 mg/kg.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Maximum Plasma Concentration (Cmax) Standardized
|
1.266 g•h/L
Standard Deviation 0.338
|
1.271 g•h/L
Standard Deviation 0.312
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Incremental in vivo recovery was calculated as the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg/kg dosed).
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Incremental in Vivo Recovery
|
1.787 mg/dL/(mg/kg)
Standard Deviation 0.458
|
1.770 mg/dL/(mg/kg)
Standard Deviation 0.442
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Classical in vivo recovery was calculated as: 100 x the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma) x the plasma volume (mL), divided by the exact dose of Octafibrin/FIBRYGA® or Haemocomplettan® P/RiaSTAP(TM) (expressed as mg).
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Classical in Vivo Recovery
|
64.397 percentage
Standard Deviation 11.519
|
66.046 percentage
Standard Deviation 11.635
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax)
|
2.148 h
Standard Deviation 1.475
|
1.417 h
Standard Deviation 2.054
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Terminal Half-life (t½)
|
75.940 h
Standard Deviation 23.831
|
69.378 h
Standard Deviation 16.006
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Mean Residence Time (MRT)
|
106.272 h
Standard Deviation 30.927
|
98.977 h
Standard Deviation 20.812
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Clearance
|
0.665 mL/h/kg
Standard Deviation 0.197
|
0.804 mL/h/kg
Standard Deviation 0.255
|
SECONDARY outcome
Timeframe: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatmentPopulation: Pharmacokinetic (PK)-per protocol dataset: All randomised participants who received ≥ 90% of the treatment (T) doses, had any post-T data, did not receive any fibrinogen (F) containing blood products between T and 14 days post-T in both study periods; had sufficient PK data for analysis; had a ≥ 50 mg/dL increase in plasma F within 4 hours post-T.
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, and at 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Outcome measures
| Measure |
Pharmacokinetic (PK)-Per Protocol Dataset
n=21 Participants
Ratio comparison of participants who received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once, and participants who received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once
|
Haemocomplettan® P/RiaSTAP(TM)
n=21 Participants
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss)
|
70.158 mL/kg
Standard Deviation 29.860
|
76.631 mL/kg
Standard Deviation 19.579
|
Adverse Events
Octafibrin/FIBRYGA®
Haemocomplettan® P/RiaSTAP(TM)
Serious adverse events
| Measure |
Octafibrin/FIBRYGA®
n=22 participants at risk
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
|
Haemocomplettan® P/RiaSTAP(TM)
n=22 participants at risk
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
Other adverse events
| Measure |
Octafibrin/FIBRYGA®
n=22 participants at risk
Participants received Octafibrin/FIBRYGA® 70 mg/kg body weight (BW) intravenously once.
|
Haemocomplettan® P/RiaSTAP(TM)
n=22 participants at risk
Participants received Haemocomplettan® P/RiaSTAP(TM) 70 mg/kg BW intravenously once.
|
|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Gastrointestinal disorders
Gingival bleeding
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
General disorders
Asthenia
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
General disorders
Fatigue
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
General disorders
Pain
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
General disorders
Pyrexia
|
9.1%
2/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
13.6%
3/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Immune system disorders
Mild allergic skin reaction
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
9.1%
2/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Infections and infestations
Urinary tract infection
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Injury, poisoning and procedural complications
Animal bite
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Injury, poisoning and procedural complications
Contusion
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Investigations
Haemoglobin decreased
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
2/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
9.1%
2/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Nervous system disorders
Headache
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
9.1%
2/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
|
Vascular disorders
Haematoma
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
4.5%
1/22
Safety analysis dataset: All randomised participants who received at least 1 infusion of study medication (any part of an infusion of Octafibrin/FIBRYGA® and/or any part of an infusion of Haemocomplettan® P/RiaSTAP(TM)).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Octapharma agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Octapharma supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial. Octapharma also reserves the right to review data prior to publishing and provide comments/changes within a certain time period.
- Publication restrictions are in place
Restriction type: OTHER